Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis

Impact of Theraworx Foam on Pain and Motion and Patient-Reported Outcomes in Thumb Arthritis

Thumb carpometacarpal osteoarthritis (CMC OA) affects up to 33% of people over the age of 40, which leads to inflammation, pain, and weakness of the CMC joint. Treatment modalities are both conservative and surgical with surgical options including osteotomy, bone excision, ligament reconstruction, and various prosthetic implants. The conservative treatment options, however, are limited to NSAIDs and bracing or steroid injections.

Advances in topical therapies have the potential to deliver focused treatment to the CMC joint. Novel treatment of inflammation can potentially reduce inflammation and pain associated with progressing osteoarthritis. Theraworx Relief is an FDA registered foam that has theoretical impact on inflammation reduction in human subjects treated with the topical foam.

Study Overview

• Status: Completed
• Conditions: Arthritis
• Intervention / Treatment: Drug: Theraworx; Drug: Placebo

Detailed Description

This pilot study seeks to investigate potential benefit in the use of Theraworx Foam in patients diagnosed with thumb CMC OA. Patients presenting to the upper extremity orthopedic surgery clinic for thumb/hand/wrist pain will be diagnosed by a Board Certified Hand Surgeon as per standard protocols. Patients who are recommended to follow a conservative treatment modality and are interested in participating in this study will be randomized into treatment or control groups. Both groups will undergo symptom assessment, strength testing, and range of motion testing prior to starting the standard conservative treatment of bracing. The treatment group will use the TheraWorx topical foam and the compression wrap nightly for 2 weeks for at least 6 hours per night. Control group will use a compression wrap for the same time period. Both groups will return at 1 and 2 weeks for repeat strength and range of motion testing and symptom assessment.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • Kaufmann Building
    • Pittsburgh, Pennsylvania, United States, 15213
      • Montefiore Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Thumb CMC arthritis
2. greater than or equal to age 18
3. Interested in non-operative treatment of thumb arthritis

Exclusion Criteria:

1. Recent corticosteroid injection into the thumb joint
2. Non-English speaking
3. skin lesions or rashes on the thumb
4. current use of topical anti-inflammatory medications
5. concomitant thumb/wrist diagnoses that would impact the results (as determined by the PI)
6. known allergy to magnesium

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Foam and Compression Wrap; Patients will use Theraworx foam and a compression wrap	Drug: Theraworx; Theraworx foam applied to skin and/or compression wrap
Placebo Comparator: Placebo Foam and Compression Wrap; Patients will use placebo foam and a compression wrap	Drug: Placebo; Placebo foam
Experimental: Foam alone; Patients will use Theraworx foam without compression wrap	Drug: Theraworx; Theraworx foam applied to skin and/or compression wrap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Rating Scale	patient rated pain on scale of 0-10 (0 no pain and 10 maximum pain). The mean score at 2 weeks is reported, not the change from baseline.	2 weeks
Disabilities of the Arm, Shoulder, and Hand (DASH) Score	patient rated outcome score on scale of 0-100, with 0 being no disability and 100 complete disability, mean value at 2 weeks is reported	2 weeks
Thumb Range of Motion	This measures range of motion of the thumb in degrees from 0-90 degrees (0 degrees would be no motion and 90 degrees full motion), 2 week data is presented as a mean.	2 weeks
Grip Strength	This measures grip strength in pounds (0 is no grip strength 150 is maximum grip strength), mean grip strength in pounds reported at 2 weeks	2 weeks
Pinch Strength	This measures pinch strength in pounds (0 is no pinch strength and 40 is maximum pinch strength), mean pinch in pounds reported at 2 weeks	2 weeks

Collaborators and Investigators

• Sponsor: John Fowler
• Investigators: Principal Investigator: John R Fowler, MD, Univ. of Pittsburgh Orthopaedic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2018
• Primary Completion (Actual): July 30, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: STUDY18090019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No